EFS was established by the FDA as a way to shorten the timeline to approval for devices in the U.S.

Prior to the EFS program devices took longer to receive approval. shifting clinical program to Europe.

Prior to the EFS program, the overall timelines to market for Class III devices did not sync with investor timelines.

Without the EFS program, many Class III device companies would have ceased to exist.

The elimination of non-value added activities and the introduction of risk mitigation guides EFS.

A company can make changes to the device design mid-stream in an Early Feasibility Study (EFS).

A successful EFS can be extended and transition right into a pivotal trial.